Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
The amendments submitted on 07/16/2026 have been entered.
Claims 1,5,7,9-10,16,18 and 20 are pending.
Claims 1,5,7,9-10,16,18 and 20 are examined herein.
Claim Interpretation
Claim 16 recites “the herbicide-resistant plant or conferring or enhancing the plant’s resistance to the herbicide” is interpreted by the examiner to reference the plant used in the cross and not the progeny resulting from the cross.
Claim 20 recites “herbicide-resistant rice plant prepared by the method according to claim 9” which is interpreted by the examiner to only reference the plants that inherit the overexpressed HIR1 gene in the expression vector.
Informalities
Priority Document
As shown in the bib data sheet mailed on 04/23/2026, an English translation of the priority document is required.
Information Disclosure Statement
A newly signed IDS form is uploaded with this office action to include further annotations.
Specification
The objections to the specification are maintained because the tables are improperly labeled. For example, there are two tables labeled “table 1” and the tables in example 5 are unlabeled.
Withdrawn Objections and Rejections
The examiner acknowledges the newly filed claims and specification filed on 07/16/2026. The responses to the Applicant’s remarks (filed on 07/16/2026) to the First Office Action Non-Final rejection from 04/23/2026 are below.
Objections to Claims 7,16 and 18 are withdrawn because of amendments to the claims.
Rejections under § 112(b) to Claims 1,5,7,9-10,16,18 and 20 are withdrawn due to amendments of the claims.
Rejections under § 112(b) to Claims 2-4,8,11-15, 17, and 19 are moot due to cancelation of the claims.
Rejections under § 112(a) to Claims 1,5,7,9-10,16,18 and 20 are withdrawn due to amendments of the claims.
Rejections under § 112(a) to Claims 2-4,8,11-15, 17, and 19 are moot due to cancelation of the claims.
Rejections under § 101 to Claims 1,5, and 9 are withdrawn due to amendments of the claims.
Rejections under § 101 to Claims 3-4,8,14, and 17 are moot due to cancelation of the claims.
Rejections under § 102 to Claims 1,5,9-10, and 20 are withdrawn due to amendments of the claims.
Rejections under § 102 to Claims 3-4, 8, 14, 17, and 19 are moot due to cancelation of the claims.
The Improper Markush Group rejection on Claims 1, 5,7, 9-10,16, 18 and 20 are withdrawn due to amendments to the claims.
The Improper Markush Group rejection on Claims 2-4,8,11-15, 17, and 19 are moot due to cancelation of the claims.
Claim Objections
Claim 1 is objected to for using “plant” instead of “plant’s” in lines 2 and 4.
Claim 1 is also objected to for using “HIR1” instead of “HIR1” in line 12.
Claim 5 is objected to for using “plant” instead of “plant’s” in line 2.
Claim 10 is objected to for using “the” before “step” in line 5.
Claim 16 is objected to for using “plant” instead of “plant’s” in line 2 before “resistance to the herbicide”.
Claim 18 is objected to for using “plant” instead of “plant’s” in line 2 before “resistance to the herbicide”.
Claim 20 is objected to for using “the” before “step” in line 5.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (a)
The text of these sections of Title 35 U.S. Code, not included in this action, can be found in a prior Office action.
Written Description
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has clarified the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material". Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus".
Applicant broadly claims a method for preparing a herbicide-resistant rice plant by overexpressing the HIR1 proteins (i.e. SEQ ID NOS:1 and 4-5) by inserting an exogenous fragment into the promoter region of the HIR1 gene.
Applicant describes:
A method for boosting resistance to HPPD-inhibiting herbicides (i.e. isoxaflutole, mesotrione, tembotrione, y13287, topramezone, and pyrasulfotole) using SEQ ID NO: 1 in rice.
Sequences ZmHIR1 and SqHIR1 (SEQ ID NOs:4-5) also conveyed isoxaflutole resistance when overexpressed in rice and was described in example 5 of the specification.
The YX6 rice mutant had a 2X35S promoter element in the promoter of LOC_Os02g09720 gene. It was in the reverse orientation and also resulted in the loss of a 48 bp sequence in the original promoter.
Promoters are defined as “non-coding nucleotide sequence located upstream of a gene that can initiate the expression of a downstream gene”.
With the exception of a promoter being upstream of a gene (page 19 paragraph 2) and approximately 2 kb upstream of the gene in rice (Example 2), the instant disclosure and the instant claims do not set forth clear structural characteristics essential to identifying promoters for genes encoding proteins with SEQ ID NOS:1 and 4-5 (i.e. HIR1 genes in Rice, Corn, and Sorghum). Additionally, it does not describe all possible exogenous fragments that can be inserted into the promoter region that are capable of inducing overexpression of HIR1 genes. Thus, the Specification fails to overcome the unpredictability of reducing to practice the large numbers of exogenous fragments that can be inserted into the unspecified promoter region of HIR1 genes.
Given Applicants have provided a very vague description of all possible exogenous fragments and their association with the claimed phenotype of conveying HPPD-inhibitor resistance, it remains unclear what features or method steps are capable of performing the claimed function.
The Specification fails to provide an adequate written description to support the breadth of the claims. Therefore, one skilled in the art would not have recognized Applicants to be in possession of the claimed invention at the time the application was filed. See Written Description guidelines published in 2008 online at https://www.uspto.gov/sites/default/files/web/menu/written.pdf.
Scope of Enablement
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for generating rice plants with resistance to HPPD-inhibiting herbicides, it does not reasonably provide enablement for conferring HPPD-inhibitor resistance in all possible plant species. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with the claim.
Applicant broadly claims a method for preparing a herbicide-resistant rice plant by overexpressing the HIR1 proteins (i.e. SEQ ID NOS:1 and 4-5) by inserting an exogenous fragment into the promoter region of the HIR1 gene.
A method for boosting resistance to HPPD-inhibiting herbicides (i.e. isoxaflutole, mesotrione, tembotrione, y13287, topramezone, and pyrasulfotole) using SEQ ID NO: 1 in rice.
Sequences ZmHIR1 and SqHIR1 (SEQ ID NOS:4-5) also conveyed isoxaflutole resistance when overexpressed in rice and was described in example 5 of the specification.
The YX6 rice mutant had a 2X35S promoter element in the promoter of LOC_Os02g09720 gene. It was in the reverse orientation and also resulted in the loss of a 48 bp sequence in the original promoter.
Promoters are defined as “non-coding nucleotide sequence located upstream of a gene that can initiate the expression of a downstream gene”.
Claim 1 is drawn to editing a promoter of an HIR1 protein with SEQ ID NOS: 1 and 4-5 in rice plants. This indicates that the gene and promoter are already present in the rice plant. However, the specification recites SEQ ID NOs:4-5 are Corn and Sorghum proteins (see tables in Example 5). Because SEQ ID NOs: 4-5 are not present in rice plants, their promoters cannot be modified by inserting an exogenous fragment.
Furthermore, Sadravi, Shekoofeh, June Lee, and Jianfeng Xu. "Advances in promoter engineering strategies for enhanced recombinant protein expression in plants." Frontiers in Plant Science 16 (2025): 1747353 teaches “native promoters often contain cis-regulatory elements whose functions are not fully understood. This complexity can complicate efforts to fine-tune expression levels or engineer predictable promoter performance across different systems”. Because native cis-regulatory elements are not well understood and have complex roles in regulating gene’s expression there is unpredictability as to if any exogenous fragment inserted into the HIR1 promoter would lead to HIR1 overexpression.
Given the absence of guidance in the specification, and given the relatively high level of unpredictability in the art, one of skill in the art cannot predict the effect of introducing the myriad of
claimed exogenous fragments, and their causal relationship to conferring HPPD-inhibitor resistance through overexpression. Accordingly, given the lack of guidance in the instant Specification, undue trial and error experimentation would have been required for one skilled in the art to use the claimed invention.
Response to Applicant’s Arguments
The Applicant’s amendments to the claims have addressed the rejections and objections on pending Claims 1, 5, 7, 9-10,16, 18 and 20. Thus any arguments are moot, and the examiner agrees with the amendments.
It is noted that the following describes a new rejection necessitated by the claim amendments. The §112 (a) rejection to Claim 1 was necessitated by the vast number of exogenous fragments claimed, unpredictability in the art of engineering promoters, and the fact that rice does not encode genes for HIR1 proteins with SEQ ID NOS: 4 and 5.
Subject Matter Free of Art
Claims 1, 5,7, 10, 16, 18, and 20 are directed to a method of preparing herbicide-resistant rice plants by overexpressing HIR1 protein with SEQ ID NOS:1 and 4-5 by engineering the HIR1 protein’s promoter or transforming a plant with a vector that induces overexpression of the HIR1 protein. These methods also encompass a method for preparing a hybrid plant using a plant overexpressing the HIR1 protein and methods for controlling an unwanted plant at a plant cultivation site. The relationship between the overexpression of this protein and HPPD-inhibitor resistance appears unknown in the art at the time of filing.
Conclusion
Claim 1 is rejected.
Claims 5, 10, 16, 18 and 20 are objected to for informalities as stated above.
Claim 7 is not allowable for being dependent upon a claim that is objected to.
No claims are allowed.
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office
action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded
of the extension of time policy as set forth in 37 CFR § 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from
the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing
date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH
shortened statutory period, then the shortened statutory period will expire on the date the advisory action
is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be
calculated from the mailing date of the advisory action. In no event, however, will the statutory period for
reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W MEYER whose telephone number is (571)272-3733. The examiner can normally be reached Monday - Friday 8:00 am- 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE W MEYER/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662
